Device and method for applying lubricating or lumen straightening substances to the urethra by means of a telescoping insertion aid

Abstract

The invention relates to a device for draining urine from the bladder of a patient, comprising a retention component to be placed in the bladder and urethra and a retractable insertion aid of tubular or hose-like construction, which is placed in the retention component and is easy to insert or pass through the urethra, the inner lumen of the insertion aid offering the possibility of applying a lubricating and lumen straightening substance into the urethra, wherein a storage container for accommodating a preferably gel-like substance can be mounted on the proximal end of the insertion aid, the substance being able to be applied from an opening at the tip of the catheter through the insertion aid into the urethra without backflow into the proximal gap between insertion aid and catheter; furthermore, different embodiments of the device are described, as well as a method which not only enables the process of hole cover and cleaning preparation for the introduction of the catheter to be carried out by hand, but also allows the insertion of the catheter into the bladder to be carried out by guiding with only one hand of the user.

Description

TECHNICAL FIELD

[0001] The present invention relates to a device and a method for draining urine from a patient's bladder. BACKGROUND

[0002] A urinary catheter for continuously draining urine from a patient's bladder aseptically into a collecting container is created in medical practice and various embodiments thereof are known. A bladder indwelling catheter is usually inserted into the bladder by transurethral catheterization. In contrast to bladder catheterization with a disposable catheter, in which case the catheter-like tube is pushed through the urethra into the interior of the bladder only intermittently, i.e. only for the actual duration of the emptying of the bladder, the catheter for permanently draining urine transurethrally is usually equipped at its distal end with a balloon-like anchoring element (indwelling balloon), the main function of which is to fix the position of the catheter tip containing the urine within the bladder.

[0003] In the case of the so-called indwelling catheters of the vast majority of known structural types, these indwelling balloons are composed of elastically stretchable hose material, which adheres to the shaft of the catheter and as far as possible without any pre-forming as a smooth, wrinkle-free, cylindrical hose body (cuff). By means of filling with an incompressible liquid medium, the cylindrical hose body is inflated into an approximately spherical balloon body at a correspondingly high filling pressure. The disadvantage of this type of anchoring balloon inflated by a high filling pressure is mainly that the balloon is relatively hard due to the expansion of the cuff. In the case of longer indwelling of the balloon, in the support area of this rigid "hard" balloon located at the base of the bladder, particularly in the area of the so-called trigone of the bladder, an erosive change and to some extent a clear ulceration of the bladder mucosa can occur. In the presence of persistent bacteria in the urine, a chronic infection of the urinary tract can develop on the basis of such tissue defects. Current research in the field of "urinary tract infections" (UTI) assumes that the epithelium of the bladder and urethra, which is as intact and uneroded as possible, is a necessary prerequisite for avoiding chronic urinary tract infections.

[0004] In addition to the conventional cuff-based catheters, indwelling elements based on prefabricated balloon components are also known from the literature. Such components are described, for example, in EP 1448259 or PCT / IB2015 / 002282. Here, the indwelling is ensured by balloon components which are already shaped during the manufacture of the catheter to the working dimensions required for the respective function. These balloon elements are composed of a film-like, thin-walled but high-strength material, which is applied less extensively on the catheter shaft in the unfilled state, so that the shaped balloon component can be pushed conveniently and without irritation through the urethra when the catheter is inserted.

[0005] Furthermore, in the most recent literature on the subject of UTI, it is repeatedly pointed out that the conventional catheter tip has a traumatic effect on the tissue of the top of the bladder exposed to the tip. The often relatively stiff tip, which extends beyond the indwelling balloon and like a finger into the intracavitary space of the bladder, penetrates the tissue of the top of the bladder in the case of constant exposure and thus often causes further damage directly related to the catheter.

[0006] Embodiments of catheter tips are known which are designed in different ways to prevent damage to the urethral wall, in particular when inserting or pushing the catheter through the urethra, and which are advantageous overall for the placement of the catheter. Furthermore, certain structural types also attempt to prevent damage to the top of the bladder. For example, double-balloon devices are described (e.g. of the Duette type from Poiesis Medical Ltd.), in which the tip of the catheter is protectively accommodated by a spherical balloon-like element, while a further balloon element is placed in a retaining manner on the bottom of the bladder. In the case of the Duette, urine is discharged through openings of the catheter shaft between the two balloons.

[0007] Another traumatic effect directly on the urinary tract is caused by the structure of the urine discharge shaft section of conventional catheters. The shaft proximal end is connected to the balloon which is indwelling in the bladder and discharges urine transurethrally. These shaft elements are usually constructed from a relatively thick-walled hose material based on silicone rubber or from a material based on natural rubber. The thick-walled design of the shaft wall on the one hand ensures that the urine discharge lumen does not close due to kinking when the shaft is bent or twisted axially. On the other hand, the thick-walled structure of the shaft ensures that the higher pressure acting in the balloon does not lead to a collapse of the urine discharge lumen of the shaft when the balloon sleeve elastically expands into a spherical balloon. The required shaft wall thickness for the balloon filling pressure in particular limits the diameter which can be achieved in terms of structure for the urine discharge lumen. Discharge through a smaller diameter often leads to an early scabbing or gradual closure due to the continuous deposition of urine components. In order to achieve as long a service life as possible, therefore, efforts are made to achieve as large a lumen diameter as possible, which in turn requires a larger shaft outer diameter. The shaft outer diameter required for conventional catheter designs, in combination with the rigidity of the shaft material, often leads to a clear erosion of the urethral epithelium, which in the case of long-term indwelling often leads to an inflammatory process and in turn to a cicatricial narrowing of the urethra.

[0008] Another factor which promotes the development of chronic urinary tract infections is the so-called accumulation of residual urine in the bladder. Residual urine can only be discharged from the bladder with a time delay and thus easily accumulates a large number of bacteria. Different embodiments are known which reduce the "pooling" of urine, mainly by discharging urine through openings of the catheter shaft which are positioned in particular close to the bottom of the bladder.

[0009] To avoid injuries when placing the catheter, gelling substances have been successfully used. On the one hand, these gelling substances reduce the friction between the catheter shaft surface and the urethral epithelium. In addition to this lubricating effect, the gels can also temporarily straighten or fill the urethral lumen. Thus, the catheter tip and the catheter shaft can be optimally inserted with low friction through the urethral lumen when the urethral lumen is in a substantially circular straightened state.

[0010] Catheters are usually packaged in a kit with all the instruments required for placing the catheter. The ready-to-use kits are usually unnecessarily extensive and in many cases no longer self-explanatory during the procedure and hinder the application of the product. SUMMARY

[0011] It is therefore an object of the present application to avoid the above-mentioned disadvantages of the prior art.

[0012] To solve the above-mentioned problems, the present application proposes within the scope of a device for draining urine from a patient's bladder a functional unit, comprising

[0013] a) a rod-shaped indwelling component which can be placed in the bladder and the urethra, the indwelling component draining in the form of a catheter and having at least one drainage hole in the distal tip region of the rod-shaped indwelling component; and

[0014] b) a retractable insertion aid inserted into the rod-shaped indwelling component, the insertion aid being easy to insert and pass through the urethra and comprising a tubular or hose-like structure with a tip opening for releasing a lubricating and / or lumen straightening substance through the opening at the end.

[0015] Within the scope of the present patent application, the terms "indwelling component", "indwelling unit", "catheter" and "catheter" are used largely in the form of synonyms.

[0016] The present application describes in particular a catheter application-optimized connection to an insertion element which is reversibly removable in the draining lumen of the catheter and which stabilizes the catheter shaft for insertion into the urethra and allows the introduction of a lubricating or lumen straightening gel in the urethra in an operationally easy manner. Within the scope of the present application, the simple handling of the catheter is provided by corresponding structural modifications and accessories. The present application in particular provides a one-handed guiding of the catheter, which in the optimum case comprises lubricating the catheter tip, inserting the first third of the catheter, straightening the urethral lumen by applying the gel, continuously pushing the catheter by means of a pincer-like gripping element and blocking the indwelling balloon. Special embodiments of the device according to the present application allow the range of the catheter kit to be reduced to a minimum.

[0017] Furthermore, the application also describes an especially atraumatic design of all components of the urinary catheter which are placed in the body. The catheter shaft in particular should be in the urethra as tissue-compatible and as corrosion-avoiding as possible. Perforation-like lesions of the bladder roof by the catheter tip should be avoided. The catheter balloon should have the best possible retention and tight sealing effect in the region of the bladder outlet, with the least possible corrosion effect of the balloon wall on the epithelium. The urine drainage lumen of the catheter shaft should have the optimum size. Furthermore, the accumulation of residual urine in the bladder should be reduced to a minimum.

[0018] The application describes in particular a thin-walled or large-lumen, high- efficiency urine drainage soft tube shaft which is atraumatically retained in the urethra, with an insertion aid which is inserted into the thin-walled soft tube shaft and which, in addition to the necessary stability reinforcement of the catheter shaft for the placement of the catheter, also facilitates the release of lubricating and / or lumen straightening substances into the urethra in the region of the tip. After the catheter has been fixed, the insertion aid is withdrawn from the catheter lumen by filling the catheter balloon, so that there is a tube body in the urethra which is as flexible and friction-minimizing as possible and which avoids the corrosion-related typical lesions of the urethra in the case of a catheter insertion in the conventional manner.

[0019] In a preferred configuration, as a soft tube or tube-like main body, the insertion aid has an inner lumen of approximately 1.0 to 3.0 mm, through which the lubricating and / or lumen straightening substances are released in the tip region of the urinary catheter in which the insertion aid is accommodated. In this case, the respective substances enter the drainage lumen of the catheter at a distance as close as possible to the urine drainage opening of the urinary catheter. As an alternative, the tip of the insertion aid can project beyond the forwardly open outlet of the catheter shaft in the axial extension of the catheter portion which is retained in the bladder. In this embodiment, the insertion aid can be equipped in the region of its tip with one of the various tip structures which are conventionally used in transurethral catheterization and which facilitate the passage of the catheter through the critical bends in the urethral curve. Here, the insertion element also has an inner lumen for the administration of lubricating and / or lumen straightening substances, wherein in this case the substances are released directly from the opening in the insertion element into the urethra. After the catheter has been fixed in the bladder, the insertion aid is removed. In the preferred case, after the insertion aid has been retracted, a funnel-like outlet is formed in the front balloon radius of the catheter balloon, wherein the opening of the catheter shaft is positioned spontaneously at the bottom of the funnel when the balloon is filled.

[0020] As an alternative, the catheter shaft can have a shorter, joint-like tip structure, but which is designed in such a way that it does not protrude beyond the front radius of the balloon when the balloon is placed in situ.

[0021] Furthermore, the invention also describes a special construction of the catheter tip, which has a corrugated wall portion in the form of a bellows, which enables the tip to be rotated or bent freely or in any direction, which on the one hand facilitates the passage through the urethra and on the other hand allows the tip to be bent in all lateral directions within the bladder, so that the bladder roof is not irritated and damaged by the pointed structures of the bladder roof when the latter is resting on the distal tip of the catheter.

[0022] In all embodiments of the device according to the invention, the balloon body is preferably shaped in as flat or disc-like a manner as possible in order to reduce the formation of residual urine.

[0023] In terms of the best possible simplified handling during the catheter insertion process, a lubricating and / or lumen straightening substance can be injected into a cap-like or bag-like sheath in the first operating step, which is located at the distal tip of the catheter or at the distal end of the insertion aid in a narrow gap space between the distal tip of the catheter and the distal end of the insertion aid and distributes the substance as uniformly as possible around the catheter tip or the distal tip of the catheter in the gap space.

[0024] The catheter, which is stabilized by the insertion aid, is inserted into the male urethra in the order of 8 to 10 cm in a lance-like manner. In order to enable the catheter to be passed further in the best possible non-traumatic manner, a second quantity of gel is injected into the urethra after the insertion of the front catheter portion, which straightens the lumen of the organ and thus avoids injuries, in particular at locations where the male urethra is particularly tortuously coiled.

[0025] Within the scope of the invention, the blockage of the drainage lumen caused by the deposition of urine components is overcome by an embodiment of the maximum lumen size of the urination lumen. To this end, the thickness of the wall of the transurethral portion of the catheter is reduced as much as possible, in extreme cases to a membrane thickness. In order to avoid a torsional or kink blockage of such a thin-walled rod, the rod can be equipped with a corrugated profile of the stabilization lumen over the entire length or only in specific structure-related sections. In combination with a material having a high elastic return force, such as polyurethane, the rod of such a profile can be equipped with the property of a self-straightening lumen, which, although it enables a flexible bending of the rod with elastic action and a temporary radial collapse of the lumen that is easily caused, on the other hand ensures a reliable self-straightening and unfolding effect of the lumen.

[0026] Furthermore, in combination with the thin-walled rod wall of the tubular membrane, a rod-like, hose-like, tube network-like structure can also be employed, which extends freely within such a drainage tube in a torsion-inhibiting and stable manner.

[0027] The application preferably uses balloon components with a special shape as described, for example, in PCT / IB2015 / 002282. Preferably, these balloons made of a thin-walled but at the same time highly dimensionally stable soft film are filled with air only incompletely, only loosely. Due to the placement in a loose, non-stretched state, a traumatic erosion of the epithelium covering the bladder can be largely avoided. In the case of a balloon filled in an unexpanded and loose manner, only forces acting in the bladder are absorbed by the balloon. In this case, the filling pressure is in the range of a few millibars. In the unloaded state of the balloon, these filling pressures do not exceed or only slightly exceed the intravesical pressure present in the patient's bladder.

[0028] As described in PCT / IB2015 / 002282, such a balloon can also be equipped with a cylindrical urethral tip with a diameter tapering. Here, the indwelling bladder balloon portion transitions in the proximal direction into a sealed urethral balloon portion. The combined bladder-urethral balloon body is preferably equipped with a "residual" diameter in the urethral portion, which is about 0.5 to 1.5 times, preferably 0.5 to 1.0 times, larger than the diameter of the urethral lumen. By this, the balloon portion that is too large in diameter stress-free and as dimensionally independent as possible rests against the urethral wall in the case of a radially oriented fold or intussusception forming a sheath wall. By the residual oversize, it is ensured that all urethral portions can be sealed in a loose tampon-like manner. Furthermore, fluctuations in the diameter of the urethral lumen can also be compensated by the residual diameter.

[0029] As an alternative, less preferred embodiment, the urethral portion of the shaped balloon body can be dimensioned so that it corresponds substantially or is smaller than the diameter of the respective urethra.

[0030] The catheter balloon used according to the application is preferably filled with a gaseous medium or air. The filling medium is fed by means of a feed line integrated into the shaft wall, but can also be fed by means of a feed line extending freely in the shaft lumen.

[0031] The application also takes into account less preferred embodiments in which the described preformed balloon assembly is dispensed with and instead a conventional indwelling component is provided which is elastically deployed from a section of hose.

[0032] The indwelling component and the insertion aid can consist of materials having the same hardness. Preferably, however, the materials of the indwelling component and the insertion aid differ from one another at least in terms of their hardness.

[0033] Both components consist of a plastic, preferably a thermoplastic, a duroplast or an elastomer, whereby the material hardness is preferably measured in Shore hardness. In this case, the hardness values are particularly preferably taken in Shore A or Shore D.

[0034] The Shore hardness y of the material of the insertion aid should be equal to or greater than the Shore hardness x of the material of the indwelling part:

[0035] y = x,

[0036] or

[0037] y > x,

[0038] or

[0039] y > x.

[0040] These differences in Shore hardness, in particular according to Shore A, should be defined in such a way that:

[0041] y - x > 0,

[0042] or:

[0043] y - x > 1,

[0044] or:

[0045] y - x > 2,

[0046] or:

[0047] y - x > 5,

[0048] or:

[0049] y - x > 10,

[0050] or:

[0051] y - x > 20.

[0052] The method of inserting a catheter into the bladder of a patient according to the invention is characterized in that a lubricating and / or lumen straightening substance is released from a compressible storage container on the basis of a finger or hand compression of the storage container.

[0053] In this case, a ready-to-use catheter device is used, which comprises a rod-shaped indwelling part which can be placed in the bladder and urethra, which indwelling part drains in the form of a catheter and has a drainage hole in the region of the distal tip of the rod, and a retractable insertion aid which is inserted into the indwelling part, which insertion aid is easy to insert and to pass through the urethra and comprises a tubular or hose-like structure with a tip opening for releasing a lubricating and / or lumen straightening substance at the end, a storage container with the lubricating and / or lumen straightening substance being connected or connectable to the proximal end of the insertion aid. BRIEF DESCRIPTION OF DRAWINGS

[0054] Different embodiments of a urinary catheter device according to the present application are described in the drawings in combination with special functional accessory parts for single-handed catheterization. Among others:

[0055] Figure 1 An embodiment is shown, in which an insertion element applying a substance or stabilizing the catheter shaft is inserted into the urine discharge lumen of the urinary catheter;

[0056] Figure 2 An embodiment is shown, in which an insertion element applying a substance or achieving stabilization is inserted into the urine discharge lumen of the urinary catheter such that the tip of the insertion element protrudes out of the distal opening of the catheter shaft remaining in the body;

[0057] Figure 2a A special embodiment of the tip of the insertion element is shown, which is formed with a corrugated profile;

[0058] Figure 2b A corresponding embodiment of the distal end of the catheter remaining in the body is shown, which is formed in a corrugated form;

[0059] Figure 2c An insertion element is shown, which is formed from a single piece with an integrated end compressible substance reservoir;

[0060] Figure 2d A special embodiment of the insertion element is shown, which has an end funnel-like receptacle for inserting and opening a structurally separate storage container in a perforated manner;

[0061] Figure 3a A special embodiment of the catheter shaft is shown, which is formed in a corrugated manner in sections or over the entire catheter shaft;

[0062] Figure 3b Another embodiment of the catheter shaft is shown, which has a tubular membrane-like structure with particularly thin walls;

[0063] Figure 4 A storage container for a lubricating and / or lumen straightening substance is shown, which can be compressed in a latching manner;

[0064] Figure 5 A special arrangement of a cap-like element for lubricating the catheter tip is shown;

[0065] Figure 6 A filling device for filling the balloon of the catheter is shown, which can be compressed in a bellows-like manner;

[0066] Figure 7 A holding device for holding the catheter in a U-shaped loop is shown for inserting the catheter in an optimized and ready-to-use manner by means of only one hand;

[0067] Figure 7a a special forceps or pincer mechanism for gripping the catheter shaft is shown; and

[0068] Figure 8 a special embodiment of a double-layered surgical drape is shown, which the user can pick up like a glove and move to the opening in which the catheter is to be inserted. DETAILED DESCRIPTION

[0069] Figure 1 An embodiment variant of the catheter device 1 is shown, in which the catheter shaft 2 of the device is equipped with a balloon 3 which has been shaped in the manufacturing process to the working dimensions required for the catheter to be left in the bladder, wherein the balloon is preferably made of a thin-walled polyurethane film which can only be slightly expanded in volume. A hose-like or tube-like insertion aid 4 is inserted into the urination inner lumen 2a of the catheter shaft. The top end 5 of the catheter shaft has at least one drainage hole 6. Preferably, two or more drainage holes 6 can also be provided, which are preferably arranged in a manner distributed at equal intermediate angles on the circumference of the catheter shaft 2. For example, two drainage holes can be diametrically opposite each other, i.e. offset by 180°, while three drainage holes are offset by 120° relative to each other. In the fully inserted state, the top end of the insertion aid or its distal opening 7 is immediately adjacent to the proximal end of the drainage hole or directly covers the drainage hole. The top end of the insertion aid preferably engages precisely with the inner wall of the drainage lumen, for example in a conical or latching seal, so that the substance to be fed does not escape retrograde into the proximal portion of the drainage lumen of the catheter or into the proximal connecting gap space between the insertion aid and the catheter inner wall during application or injection through the inner lumen of the insertion aid.

[0070] In a preferred embodiment, a reservoir-like, preferably bellows-like storage container 8 is provided at the proximal end of the insertion aid, which accommodates the substance to be fed and from which the substance is delivered to the top end of the catheter by squeezing the container. In a preferred embodiment of the container, under the action of an axial compression force or alternatively a radial squeezing force, the container is transformed into an axially or radially latched state, which prevents the container from being elastically straightened again when the force is reduced. In this way, it is possible to prevent the already applied gel from being sucked back into the container.

[0071] In order to improve the fixing of the relative position of the catheter and the insertion aid, the distal portion of the container 8 has a conical portion 9, which can be inserted in a precise fit and optionally latching manner into the connector 10 of the catheter.

[0072] Figure 2One embodiment of the insertion aid 4 is shown, which has a molded or shaped tip structure 7a, which can consist, for example, of a soft plastic sol gel material and which at the tip abuts against the relatively hard shaft portion 11 of the insertion aid to pass through the urethra as untraumatically as possible. The tip 7a preferably has an inner lumen 12, which opens at the tip, through which lumen a lubricating substance can be released into the urethra in the elongation of the shaft portion 11 of the insertion aid, which is also provided with an inner lumen.

[0073] The tip 7a of the insertion aid can have a special hump-like thickening 7b in the transition to the distal end 5 of the catheter shaft, which elastically contracts under axial tension and in turn slips out of the relative position in the transition to the catheter tip when retracted. The hump 7b can optionally be provided with a longitudinal strip-like thinning, which leads to a collapse of the hump when a certain tension is overcome, in turn facilitating the retraction of the hump-like structure through the inner lumen of the catheter. The hump 7b forms a stepless and untraumatic transition in combination with the front opening 5 of the catheter. In addition, the hump is also able to accumulate the substance applied to the urethra when placing the catheter in front of and in front of the distal catheter tip 5 and push it in front of the catheter tip, so that the catheter tip remains available in sufficient quantity in the area in front of the catheter tip during the passage of the catheter through the urethra. In particular when applying a gel, the best lumen straightening effect can be achieved when inserting the catheter into the urethra.

[0074] Figure 2a In the case of the use of a relatively hard material or a material with a higher elastic return force, the tip 7 of the insertion aid 4 can also be provided with a corrugated profile 7c, which makes the tip flexible and axially bendable on all sides, but at the same time maintains the inner lumen 11 of the insertion aid. A particularly advantageous untraumatic insertion behavior can be achieved by the corrugated profile when inserting the catheter through the urethra.

[0075] Figure 2b A corresponding corrugated profile 7c can also be formed in the region of the catheter tip 5 of the catheter shaft. The tip can be bent in situ to a position P which is curved transversely, thus avoiding direct lacerating irritation and, in the course of long-term use, ulcerative damage to the bladder roof contacted by the tip.

[0076] Figure 2cA special embodiment of an insertion aid 4 is shown, in which all functional parts, including the container 8 for the substance at the proximal end, are formed from a single blank, preferably from a hose-like base body by blow molding. The distal part of the insertion aid can optionally be provided with corrugations that support axial bending. In addition, the proximal shaft part of the insertion aid can also be provided with corresponding corrugated profiles in certain parts that facilitate easier passage through the urethra. In addition, the insertion aid can be provided with a part 9 in the proximal part that is molded in a completely consistent and precise fit, which supports a positionally fixed fit into the catheter connector 10. As an alternative to being completely blow-molded from a single blank, the insertion aid according to the invention can also be produced partly or completely by an injection molding, casting or dipping process.

[0077] The insertion aid is preferably made of a material with good sliding properties, which is crucial for easily retracting the indwelling component from the device. In order to achieve this sliding ability, the basic material used may be equipped with, for example, a wax additive to form a film that reduces frictional resistance on the surface.

[0078] Figure 2d Show Figure 2c A modified embodiment of the type of construction shown, in which the storage container 8a is a separate unit structurally unconnected to the insertion aid 4, having a connector-like protrusion 9a that is inserted with a precise fit into a receiving funnel 9b of the same shape. The top end of the container has a particularly thin-walled or otherwise pre-formed surface 9c, which is perforated upon insertion, for example by a spike-like extension 9d of the stem portion extending into the receiving funnel, thereby allowing the substance to be administered to be transferred into the inserted catheter and insertion aid combination. This embodiment is particularly necessary for substances that require a special sterilization method that differs from the sterilization of the actual catheter kit, as may be the case with gel-like compounds. The container can therefore be added separately to the catheter kit and inserted into the end piece of the insertion aid only immediately prior to insertion of the catheter.

[0079] Figure 3aA special embodiment of the transurethral shaft portion 12 of the catheter is shown. In order to ensure a flow diameter inside the shaft as large as possible, the shaft wall is preferably composed of a thin-walled PUR, PVC or PVC / PUR hybrid material. In order to stabilize the thin-walled shaft structure and to avoid possible lumen closures due to buckling or twisting of the shaft, the present invention proposes a corrugated profile 13 of the shaft wall in the form of a bellows. The wave-shaped "folds" of the shaft make the respective shaft susceptible to bending and reduce possible elastic return effects due to bending or forces permanently acting on the exposed tissue by these return effects. In particular when using PUR, the achievable, buckling-free bending radius of the catheter shaft is limited without corresponding profiling of the shaft. In addition, unlike PVC, PUR has a significantly better elastic return effect when bent. The described folds 13 of the catheter shaft can be applied continuously over the entire length range or only in certain regions, in which particularly small bending radii should be adjusted on site with correspondingly less elastic stress.

[0080] For example, the corrugated shaft can have the following characteristics: outer diameter 6.0 mm, inner diameter 5.4 to 5.9 mm, preferably 5.6 to 5.8 mm, polyurethane with a Shore hardness of 85 A or 90 A, corrugation amplitude 1.0 to 1.5 mm, peak-to-peak distance of the corrugations 0.5 to 1.5 mm.

[0081] Figure 3b A transurethral shaft tube 14 of the indwelling unit 2 is shown, which has a particularly thin wall, which is reduced to a film thickness of approximately 0.05 mm, for example. One advantage that can be achieved thereby is that such a thinner shaft tube 14 can best adapt to the curvature of the urethra, so that there is no risk of damaging the inner wall of the urethra, even in the case of long-term use of, for example, one or more weeks.

[0082] In order to avoid buckling and twisting of the closed lumen of the tube film 14, the tube film is supplemented, for example, by means of a preferably freely insertable rod-, tube- or hose-like element SE1, which, in the Figure 3b The upper part in Fig. 1 shows and connects together in a correspondingly stable manner the intravesical portion VS of the catheter with the extracorporeal connector part KO over the entire length of the urethra. In the case of a hose-like embodiment of the element SE1, the lumen of the element can be used to fill the indwelling balloon.

[0083] On the other hand, in order to stabilize the tubular thin-film thin-walled rod section of the tube 14, its wall section can also be reinforced by, for example, a mesh structure SE2, which is preferably applied to the inner surface of the tube 14 in a planar and firmly connected manner. A corresponding mesh braid SE2 can also be firmly installed between two coaxially arranged tubular thin-film layers, for example, co-extruded with these layers. Instead of a mesh braid, a spiral arrangement or another planar arrangement with sufficient self-straightening properties can also be used.

[0084] It is precisely these self-straightening properties that give the otherwise very flexible tubular thin-film 14 the ability to resist bending tendencies and / or to restore or reset a twist that has occurred in the tubular thin-film 14. Both measures serve to keep the lumen open within the film-like tubular thin-film 14.

[0085] Figure 4 A reservoir-like container 8 is shown, which allows the lubricant to be released into the urethra in an easily dosable manner. The container is preferably designed as a bellows-like container, which snaps into the corresponding insertion position when the bellows are pushed together by pressing on the bottom 15 of the container, i.e. does not reset to its straightened initial size due to the elastic effect when the bellows are released. The container can carry a color field 16 corresponding to a specific amount of the substance to be applied. If the marked section is compressed or collapses as a whole, the volume corresponding to the marked section is released.

[0086] Figure 5 A front section of a catheter is shown, which has an insertion aid 4 for applying a lubricating and / or lumen straightening substance positioned therein. In order to prevent the substance stored in the insertion aid from drying out, the front discharge opening 12 of the insertion element is therefore equipped with a closure element 17, which hermetically seals the opening 12 of the insertion aid. The lower part of the element 17, which closes the opening, is surrounded by a bag-like or glove-like thin-film sheath 18, which surrounds the catheter rod in a spaced-apart gap space SR. The thin-film sheath preferably has a length of about 8 to 12 cm. If the closure 17 is removed from the discharge opening of the front opening of the insertion aid, the gel can be injected into the gap space by compressing the storage container, where the gel is distributed uniformly. The amount of gel required to fill the gap space can be given, for example, by a corresponding color marking of the section of the storage container. The user folds the marked section by applying a thumb pressure with an axial effect on the bellows bottom, in turn delivering the necessary volume into the gap space.

[0087] In addition to the color coding of the bellows section, different designed sections of the storage container, in particular different configured sections of the bellows, can realize tactile detectable or oriented partial volume releases. For example, the proximal bellows folds next to the bellows bottom can be designed to be able to be compressed more smoothly or to be able to be compressed with less resistance than the distal bellows folds, so that after an initial compression of the bellows to release a first partial volume of lubricant and / or lumen straightening substance from the proximal section of the bellows, the user perceives a perceptibly increased resistance at the transition to the distally adjacent bellows section, which signals to the user that the first partial volume has been released and the distal end of the catheter device should be inserted into the urethra before a second partial volume of lubricant and / or lumen straightening substance is released.

[0088] In this case, the cap is removed from the catheter by means of the closure element fixed on the cap top before the catheter is inserted into the urethra, facing the front of the catheter. In order to avoid the accidental insertion of the film cap into the opening, the cap is preferably equipped with a protrusion, for example leaf-shaped, of about the size of a thumb at the top, which also facilitates the removal or taking off of the cap.

[0089] Figure 6 An alternative bellows-shaped container 19 is shown, which is used to fill the retention balloon, preferably with air, wherein the bellows also preferably has a latching fold, which ensures that the bellows 19 does not spring straight again and suck the filling medium out of the retention balloon when released. The bellows 19 can be equipped with color codes 20 for metering the air volume, which respectively give the set fill level of the retention balloon, so that the retention balloon can be filled, for example, partially by about 80% of its free balloon volume, and the color codes show a complete filling or also establish a filling that turns the balloon into an expanded state that is moderately loaded. In this case, the catheter is respectively equipped with a closure or valve element for filling the retention balloon, which allows the container to be separated from the catheter self-sealingly after filling. The connecting cone 21 of the container is preferably designed such that it opens the valve in the plugged-in state and allows filling. If the cone is removed from the valve, the valve closes.

[0090] Figure 7The U-shaped configuration of the catheter kit device S, which comprises the catheter 1 according to the application, the insertion aid 4 inserted into the drainage lumen of the catheter and the connected storage container 8, 19, is shown here to be secured by a holding device 22 which adapts to the shape of the user's hand palm, which on the one hand accommodates and secures the connector-side proximal end of the catheter and on the other hand grips the distal shaft portion of the catheter. The holding device optionally has a hand grip 23 for gripping the holding device in an operationally safe manner. The thumb-side portion DH of the holding device accommodates the proximal portion of the catheter device. In a preferred embodiment, the connector portion of the catheter device is secured in a precisely fitting pre-shaped structure of the grip or holding device, for example in a latching manner. In this case, the securing enables a sufficient support function so that the gel can be delivered to the catheter tip by, for example, thumb pressure applied to the bottom of the reservoir without the connector portion being released from the securing as a result of the pressure applied by the thumb. On the other hand, after the catheter has been placed or secured in the bladder, the entire proximal connector portion can be removed by the user with a suitable resistance from the latching position. In this case, a C-shaped recess portion which accommodates the catheter shaft or connector portion is advantageous. In the process, the individual portions of the device are latched into a preferably elastically deformable holding hoop. As a result of the convex deformation or bending of the holding device, for example as a result of squeezing the holding hoop in the hand palm, the C-shaped profile of the recess portion is opened and the catheter can be released in turn.

[0091] The gel container 8 is in particular positioned in the clasp or grip so that it can be easily squeezed or compressed by the user by thumb pressure. A filling container for closing the air pocket can be arranged adjacent to the gel container. The filling container can be compressed or squeezed out in a suitable manner by thumb pressure. The air pocket-like embodiment filled with air can for example be embedded in a spoon-like recess 24 of the clasp or grip and placed substantially supportingly.

[0092] In order to ensure that the catheter is protected from contamination during placement, the holding device is equipped with a thin-walled bag-like film 27. In this case, the film bag in particular protects the catheter portion extending from the gripping forceps or pincers 25 to the connector of the catheter device. The protection bag is adapted to accommodate the central catheter shaft in a loop. The film protection allows the user to dispense with wearing sterile gloves and to insert the catheter equipped or secured in the holding device in the manner according to the application aseptically.

[0093] Figure 7aA special tweezers-like or pincer-like clamp 25 is described, which is mounted laterally to the holding device 22. If the flap 26 is loaded with thumb pressure, the clamp will grasp the catheter shaft 2 to be inserted. If the flap is released, the clamp can be shifted to a new position relative to the catheter shaft. The flap-like or pincer-like clamp is preferably embodied such that the gripping elements take on a jaw-like design and these jaws thus have a certain overhang 36, which enables the catheter to move axially within the jaws in the unloaded state of the pincers, but prevents the catheter from being released completely from the holding device and can only be achieved when the flap is manipulated in the opposite direction.

[0094] If the first ten centimeters of the catheter shaft, which are wetted by the lubricating substance, are inserted into the urethra, the catheter shaft is released in the clamp by releasing the flap, and then the flap is shifted proximally on the shaft, in which case the clamp again grasps the shaft under the pressure applied to the flap. In this way, the catheter shaft can be gradually pushed into the urethra by the user in the manner of a tweezers-like or pincer-like guide. If about two-thirds of the shaft length have been inserted into the urethra, the catheter is fixed by inflating the balloon and is completely removed from the holding device in the fixed recess or structure.

[0095] Figure 8 A special embodiment of the surgical drape 28 is shown, which consists of two layers of preferably non-woven cloth-like material, which are sealingly connected to one another in the region of the centrally arranged hole 29 by means of an adhesive or welding seam 30. The user takes the drape, the hand is inserted into the intermediate gap Z of the C-shaped opening between the two layers and finally grips around the hole 29. Direct control of the hole by means of a C-shaped grip around the hole with the thumb and index finger makes it possible for the opening to be guided in the best possible way to the surface to be cleaned around the orifice or to hold the penis or spread the labia in the best possible way. As an alternative to the intermediate gap Z, the surgical drape 28 can be equipped on the side 28a facing the patient with a larger, stylized custom-made glove-like element 31, which is connected to the plane of the side 28a facing the patient on the back. As a further preferred embodiment variant, the element 31 can be connected on the palm side to the side 28b of the surgical drape facing away from the patient. The surgical drape can be provided with a continuous slit 32 starting from the hole towards the periphery of the drape. In addition, the drape can also be equipped with bubble-cap-like compartments 34 pre-shaped for the separate accommodation of wetted swabs, preferably arranged in one line above the ulnar edge 33 of the hand holding the surgical drape. The bubble caps are closed with respect to the user by means of a tearable film 35. The user grasps the individual swabs by means of a stamp-like tip covered by a protective film, whereby the swabs are removed from the bubble caps in this way.

[0096] Furthermore, the application also describes a method for inserting a catheter into the bladder of a patient, wherein the number of components required for the cleaning and insertion process is reduced to a minimum. To this end, the ready-to-use catheter device described according to the application is advantageously combined with a glove-like surgical drape 28 which directly holds the penis or spreads the labia, which is particularly suitable for one-handed operation like the catheter device. By combining the two functional units, the glove drape and the catheter device, the user is able to perform the entire catheter insertion process without an assistant.

[0097] The two functional units are jointly encapsulated in a kit. After opening the outer packaging of the kit, the user reaches directly into the glove-like surgical drape unit and thereby takes it out of the kit. Then, the user directly holds the penis or spreads the labia. By this, the user achieves the optimal protective position of the drape relative to the orifice to be cleaned and subsequently to be inserted with the catheter. Then, the user unfolds the side portions of the drape as required and fixes these on the patient's abdomen, thighs or buttocks by means of the respective self-adhesive surfaces.

[0098] As a particular feature, the glove drape 28 optionally has a blister-like deep-drawn film compartment 34 integrated into the drape, which is opened by tearing off or removing a protective film 35 with the free hand and which contains ready-to-use swabs for cleaning the skin and mucous membranes, which are impregnated with an antiseptic agent. The swabs are removed from the blister by a stamp-like structure which is protected by a sealed deep-drawn film, thereby allowing the user to hold it directly without contamination. The swabs can then be thrown onto the surgical drape or into a bag-like structure attached to the drape.

[0099] In this case, after the cleaning is completed, the user holds the catheter device with the free hand and inserts the distal catheter portion which is lubricated by means of a gel and stabilized by means of an insertion aid which is reinforced by the insertion aid and held like a lance by the holding device into the urethra. Then, the user applies the substance which is still present in the storage container into the urethra by pressing it with the thumb and continuously grips and releases the catheter shaft by means of the clamps of the holding device to push the catheter into the bladder. While inserting the catheter, the user adjusts the penis to the respective optimal position by holding it directly or keeps the labia optimally open by spreading them with the fingers by means of the surgical drape.

[0100] If the first two thirds of the catheter are inserted into the urethra, the balloon of the catheter is blocked by squeezing the filling container with the thumb. Subsequently, the hand is removed from the glove drape combination and the proximal catheter portion is retracted from the holding device.

[0101] The insertion aid is then retracted from the device and the filling container is removed from the catheter valve. The catheter is then connected to the urination hose / bag unit.

[0102] The indwelling balloon component of the urinary catheter is preferably made by blow molding from a polyurethane tube blank previously blow molded in a separate manufacturing step, preferably in a hardness range of Shore hardness 80 A to 95 A, particularly preferably between 85 A and 90 A. The wall thickness is preferably 5 to 25 pm, particularly preferably 7 to 12 pm. In the case of material types such as PUR of the Eiastollan 1100 group of the company BASF or Pellethane 2363 of the company Lubrizol, a soft film-like structure can be blown out of the pre-extruded material by blow molding, which ideally combines a minimum wall thickness with a higher shape stability. Particularly in the case of a greater outward axial pulling force, the ultrathin PUR balloon component ensures a reliable anchoring effect.

[0103] In addition to polyurethane, the balloon element can also be made, less preferably, from similar materials that replace the soft film, for example from polyethylene-based mixtures or TPE-based raw materials. Furthermore, co-extruded starting materials can also be used for blow molding, which combine PUR and PVC in a coaxial extrusion in the raw hose.

[0104] It is also possible, less preferably, to use conventional balloon elements based on a sleeve, which are not pre-formed, elastically expandable.

[0105] Legend to the drawing

[0106] 1 device 20 color marking

[0107] 2 indwelling component, catheter 21 connection cone

[0108] 2a gap space 22 holding device

[0109] 3 balloon 23 handle piece

[0110] 4 insertion aid 24 spoon-like recess

[0111] 5 tip 25 forceps, clamp

[0112] 6 drainage hole 26 spatula

[0113] 7 opening 27 protective bag

[0114] 7a tip, tip structure 28 surgical drape

[0115] 7b bulge, thickening 28a side facing the patient

[0116] 7c corrugated profile 28b side facing away from the patient

[0117] 8 storage container 29 hole

[0118] 8a storage unit 30 seam

[0119] 9 part 31 element

[0120] 9a portion 32 gap

[0121] 9b funnel-like structure 33 edge

[0122] 9c perforable surface 34 membrane compartment

[0123] 9d thorn-like extension 35 membrane, protective film

[0124] 10 connector 36 overhang

[0125] 11 stem portion DH thumb-side holding member

[0126] 12 lumen KO connector member

[0127] 13 part, profile P laterally curved position

[0128] 14 stem portion hose S kit, catheter kit

[0129] 15 bottom SR gap space

[0130] 16 part, region SE1 rod-like element

[0131] 17 element, closure SE2 tubular element

[0132] 18 cover-like element VS intravesical portion

[0133] 19 bellows, container Z intermediate void

Claims

1. A device (1) for draining urine from a patient's bladder to a urinary hose / bag unit, comprising a) a drainage rod-shaped retention component (2) that can be placed in the bladder and urethra like a catheter, the retention component having a urine drainage cavity (2a) and at least one drainage hole (6) located in the region of the distal tip (5) of the rod-shaped retention component (2); and b) a retractable insertion aid (4) inserted into the urine drainage cavity (2a) of the rod-shaped retention component (2), the insertion aid being easy to insert and pass through the urethra and comprising a tubular or hose-like structure having a top opening (7) for releasing a substance through the top opening (7) at the distal end, It is characterized in that c) The rod-shaped portion of the retention component (2) surrounding the urine drainage cavity (2a) extends from the retention airbag (3) to the proximal external connector (10) for connecting the hose / bag unit for urination, wherein d) In the region of the proximal external connector (10) of the retention component (2), the insertion aid (4) has a region (9) formed in a manner that precisely matches and conforms to the proximal external connector (10) and can thus be fixed to the proximal external connector (10) by slight squeezing or snapping, wherein e) a substance storage unit (8) located at the proximal end of the insertion aid (4) for storing a substance having lubricating and / or lumen straightening properties, wherein f) The substance storage unit (8) is (i) directly integrally formed with the tubular or hose-like extension at the proximal end of the insertion aid (4), or (ii) is separate from the insertion aid (4) and can be inserted into the tubular or hose-like extension at the proximal end of the insertion aid (4).

2. The device (1) according to claim 1, characterized in that The substance can be administered in a sealed manner from the top opening (7) of the insertion aid (4) through the drainage hole (6) in the area of ​​the top end of the catheter, thereby reliably preventing the substance from flowing back into the gap space (2a) located between the insertion aid and the inner lumen of the drainage catheter, which is proximally adjacent to the opening of the insertion aid.

3. The device (1) according to claim 1 or 2, characterized in that The top opening (7) of the insertion aid (4) leads to the drainage lumen of the retention component (2) in a manner close to the distal drainage hole (6) of the retention component (2) or directly covers the drainage hole (6) of the retention component (2) or is aligned with the drainage hole.

4. The device (1) according to any one of claims 1 or 2, characterized in that The top end (7a) of the insertion auxiliary component (4) extends out of the distal drainage hole (6) of the retention component (2).

5. The device (1) according to claim 4, characterized in that The top end (7a) of the insertion aid (4) a) a preform with a curvature that facilitates passage through the urethra, and / or b) Preforming to increase flexibility, in the form of corrugations, so that the top end (7a) of the insertion aid (4) can be flexibly bent, the flexibility reaching more than 90 degrees.

6. The device (1) according to claim 4, characterized in that The top end (7a) of the insertion aid (4) has a raised, spherical or spindle-shaped cross-sectional expansion portion (7b) in the transition portion to the drainage hole (6) of the retention component (2) for achieving a smooth transition. The cross-sectional expansion portion is deformed under the action of a pulling force from the proximal side, so that the cross-sectional expansion portion (7b) can be pulled out through the inner cavity of the retention component (2).

7. The device (1) according to claim 1 or 2, characterized in that The proximal region of the insertion aid (4) has a funnel-shaped structure (9b) into which a structurally independent substance storage unit (8) can be inserted in a tightly sealed manner via a portion (9a) of uniform shape.

8. The device (1) according to claim 7, characterized in that The inserted substance storage unit (8) has a perforable surface (9c) at the distal end, which can be opened by a thorn-like extension (9d) of the distal region of the insertion aid (4) when the substance storage unit (8) is fully inserted into the distal end.

9. The device (1) according to claim 1 or 2, characterized in that The substance storage unit (8) is made of a corrugated tubular material.

10. The device (1) according to claim 9, characterized in that The substance storage unit (8) a) a portion (16) having a color coded pattern to encode the release of a specific volume upon compression of the portion in a snap-fit ​​manner, and / or b) having a portion (16) which, during manual compression, generates a specific resistance to folding and / or collapse, respectively, thereby enabling a tactilely perceptible transition from a first volume amount to be metered to a subsequent second volume amount.

11. The device (1) according to claim 1 or 2, characterized in that The stem portion of the retention component (2) is preformed in a corrugated manner in one or more portions (13) of the stem, thereby facilitating axial bending of the stem and reducing elastic restoring forces in the stem.

12. The device (1) according to claim 1 or 2, characterized in that The shaft portion located in the urethra portion or the portion between the retention balloon (3) and the proximal connector (10) of the retention component (2) is made of a thin-walled tubular material (14) in a film-like shape.

13. The device (1) according to claim 12, characterized in that One or more rod-shaped or tubular structures (SE1) are arranged to be exposed in the lumen of the tubular film (14) so ​​as to prevent the drainage lumen from being closed due to axial twisting or kinking of the tubular film (14).

14. The device (1) according to claim 13, characterized in that A mesh reinforcement (SE2) is firmly connected to the tubular film (14) or integrated into the tubular film, which elastically straightens the inner cavity of the tubular film (14) so ​​as to hinder axial twisting and / or return any twisting to an untwisted starting position.

15. The device (1) according to claim 1 or 2, characterized in that The distal region of the retention component (2) and / or the insertion aid (4) is provided with a cover-like element (18).

16. The device (1) according to claim 15, characterized in that The interstitial space (SR) between the cover (18) and the retention member (2) can be filled by a lubricating and / or lumen-straightening substance fed into the interstitial space (SR).

17. The device (1) according to claim 16, characterized in that The cover (18) has a closing element (17) at the top, which is firmly connected to the cover (18) and closes the outlet of the insertion aid (4) in a plug-like manner and can release the lubricating and / or lumen-straightening substance from the inner cavity of the insertion aid (4) by means of a reservoir-like expansion at the end after separation from the insertion aid (4).

18. The device (1) according to claim 1 or 2, characterized in that A unit comprising the retention part (2) and an insertion aid (4) inserted into the retention part (2) is embedded in a retaining device (22) and reversibly fixed in the retaining device, in which case a U-shaped ring-shaped structure is adopted, wherein the distal part of the unit (2, 4) is retained by a pincer-shaped or rocker-shaped opening and closing device (25), and the proximal area of ​​the unit (2, 4) carrying the connector (10) is accommodated in a groove in the retaining device (22), so that a filled bellows or container (19) inserted into or plugged onto the connector part (10) and / or a substance storage unit (8) inserted or plugged therein can be compressed or emptied by applying pressure with the thumb.

19. The device (1) according to claim 18, characterized in that The proximal area of ​​the retention component (2) is accommodated in a wrapped film-shaped protective bag (27), and the protective bag is fixedly or detachably connected to a retaining device (22) that accommodates the retention component (2).

20. The device (1) according to claim 18, characterized in that The pliers-like or seesaw-like opening and closing device (25) is capable of achieving an overlying grip (36) of the rod of the retention component (2) in the side of the opening, which prevents the rod of the retention component (2) from moving out of the grip of the pliers-like or seesaw-like opening and closing device (25) when the retention component (2) is released, and is thereby released from the retaining device (22), and only when the opening of the seesaw (26) is at its maximum will its overlying portion (36) be opened, thereby releasing the catheter rod.

21. The device (1) according to claim 1 or 2, characterized in that The material of the retention component (2) has a Shore hardness x, and the material of the insertion aid (4) has a Shore hardness y, wherein the Shore hardness y of the material of the insertion aid (4) is equivalent to or greater than the Shore hardness x of the material of the retention component (2), that is: y = x, or: y > x.

22. The device (1) according to claim 9, characterized in that When the bellows is compressed, the material is fixed in place in a locking manner and prevents the bellows from straightening again.

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